Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer
Status:
Withdrawn
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
FC-8 is a Phase II, multi-center randomized study of a continuation regimen of 5-FU/LV with
ziv-aflibercept or 5-FU/LV alone (control arm) following the induction regimen of mFOLFOX6
and ziv-aflibercept as first-line therapy for patients with metastatic colorectal cancer. The
primary aim of the study is to determine the value of adding ziv-aflibercept to the
continuation regimen of 5-FU/LV in improving progression-free survival (PFS) of patients with
metastatic colorectal cancer who have achieved at least stable disease after induction
therapy. The secondary aim is to determine the overall objective response rate (complete,
partial or stable responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).